Screening for HPV and Cervical Cancer in Young Women With Perinatally Acquired HIV (SHiP)

Imperial College London

Status: Completed

Conditions: Human Papillomavirus Infection; HIV Infections; Cervical Cancer

Treatments: Diagnostic Test: HPV serology; Diagnostic Test: Cervical cytology; Diagnostic Test: Human papillomavirus testing

Study type: Observational

Funder types: Other

Identifiers

NCT04587050

19SM5242

Details and patient eligibility

About

This is a cross-sectional, observational study of high-risk HPV status, cervical cytology and HPV vaccine uptake and response in young women with perinatally acquired HIV.

Full description

This is an observational study of cervical cytology assessment, high risk human papilloma virus (hr-HPV) status, and HPV antibody titres amongst adult women living with perinatally acquired HIV infection (PaHIV). Eligible consenting participants will have two samples taken; firstly, a cervical sample tested for cytology and Hr-HPV with the Cepheid GeneXpert HPV; secondly serum will be assessed for hr-HPV serology. All women with PaHIV, vaccinated and unvaccinated for HPV, over the age of 18 years will be eligible and will be recruited into one of two cohorts: (1) sexually active women: full study, cervical and blood sampling or (2) non-sexually active women, blood sampling only (total n=80). Follow up for abnormal smear results or hr-HPV positivity will be arranged through colposcopy.

Enrollment: 57 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Cohort 1:

• Perinatally acquired HIV aged 18+
• Sexually active
• Able to give informed consent

Inclusion Criteria - Cohort 2:

• Perinatally acquired HIV aged 18+
• Able to give informed consent

Exclusion Criteria - Cohort 1:

• Pregnancy
• Not sexually active
• Previous total abdominal hysterectomy
• Unable to give informed consent

Exclusion Criteria - Cohort 2:

• Unable to give informed consent

Trial design

57 participants in 2 patient groups

Cohort 1: Women with HIV sexually active

Description:

Women with perinatally acquired HIV aged 18 or over who are sexually active

Treatment:

Diagnostic Test: Human papillomavirus testing

Diagnostic Test: HPV serology

Diagnostic Test: Cervical cytology

Cohort 2: Women with HIV not sexually active

Description:

Women with perinatally acquired HIV aged 18 or over who are not sexually active

Treatment:

Diagnostic Test: HPV serology